Original articleOphthalmic Evaluations in Clinical Studies of Fingolimod (FTY720) in Multiple Sclerosis
Section snippets
Study Population
Analyses were based on pooled data from the phase 2 and 3 core and extension studies for MS (N = 2615, “all studies group” safety population, patients who received at least 1 dose of fingolimod). The phase 2 core study (FTY720D2201) of 6 months' duration was a double-masked, randomized, placebo-controlled study9 and had an optional long-term extension phase10 of more than 5 years. FREEDOMS5 (FTY720D2301; FTY720 Research Evaluating Effects of Daily Oral therapy in Multiple Sclerosis) was a
Results
Patient disposition and incidence of ME in the MS clinical studies of fingolimod are shown in Figure 2 (available at http://aaojournal.org).
Among 2615 patients of the all studies group safety population assessed in this pooled analysis, 19 cases of ME were confirmed by the retina specialist on the DSMB. Among 1176 patients who received fingolimod 0.5 mg, 4 (0.3%) developed ME, and among the 1302 patients who received fingolimod 1.25 mg, 15 (1.2%) developed ME. Macular edema occurred in both
Discussion
Macular edema is an important cause of central vision loss and is associated with a serious impact on the social and economic aspects of an individual's life.11 Beyond the direct impact on vision, and thus disability, it has also been found that patients with MS and ME can have significantly worse disability (as measured by the Expanded Disability Status Scale12) and rate of disease progression (as measured by the MS Severity Scale13) than those without ME.14 The cause and pathophysiology of ME
Acknowledgments
The authors thank Uma Kundu and Hashem Salloukh (Medical Communications, Novartis Healthcare Pvt. Ltd.) for providing medical writing support. This encompassed preparing the first draft, checking content and language, formatting, referencing, preparing tables and figures, incorporating the authors' revisions, and submission, all under the direction of the authors.
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Manuscript no. 2012-873.
Financial Disclosure(s): The author(s) have made the following disclosure(s): M.A.Z. is a consultant for Novartis Pharma AG (Basel, Switzerland); L.M.J. was a former consultant for Novartis Pharma AG (Basel, Switzerland); R.D.J. is a consultant for Novartis Pharma AG (Basel, Switzerland); A.T.R. is a consultant for Novartis Pharma AG (Basel, Switzerland); G.F. is a full-time employee of Novartis Pharmaceuticals Corporation (East Hanover, NJ); W.C. is a full-time employee of Novartis Pharma AG (Basel, Switzerland); D.T. is a full-time employee of Novartis Pharmaceuticals Corporation (East Hanover, NJ); and X.J. is a full-time employee of Novartis Pharmaceuticals Corporation (East Hanover, NJ). At all stages the authors have had control over the content of this manuscript, for which they have given final approval and take full responsibility. Novartis Pharma AG enforces a “no ghostwriting” policy. As funding sponsors, they have had the opportunity to review the manuscript but do not have the authority to change any aspect of the manuscript.
Funding: The studies were funded by Novartis Pharma AG (Basel, Switzerland) and are registered with Clinicaltrials.gov (Phase 2 core: NCT00333138; Phase 2 extension study: NCT00235430; FREEDOMS and extension study: NCT00289978; TRANSFORMS and extension study: NCT00340834). The sponsor participated in the design of the study, conducting the study, data collection, data management, and data analysis, interpretation of the data, preparation, and review and approval of the manuscript. Supported in part by unrestricted grants from the Research to Prevent Blindness, Inc. (New Jersey Medical School, Northwestern University), the Eye Institute of New Jersey, and the NJ Lions Eye Research Foundation.